To perform Quality Assurance actives as per GMP & Safety
Reporting Structure: Reports to Manager - QA
Key Stakeholders:
Internal: Production, QC & Safety
Experience: 6-10 Year Experience in AQA
Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / B. Pharmacy / M. Pharmacy
Key Roles & Responsibilities
1. Review of In-process analytical data before release.
2. Review of Intermediates, stability batches and Finished products analytical data.
3. Having the knowledge on the analytical method validations and method transfers.
4. Review of System audit trails for all the types of instruments in QC.
5. Review of the calibration data of the instruments on daily basis.
6. Verifying the SOP s compliance in shop floor.
7. Carry out the audits as and when required for laboratory system compliances.
8. Investigation of the incidents, OOS, OOT & Root cause analysis.
